BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 4974704 · Received August 5, 2015

    Report

    Report Number
    2432235-2015-00353
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC EVALUATED THE INSTRUMENT DATA AND DISCOVERED THAT PATIENT B WAS SCHEDULED MANUALLY BY THE OPERATOR WHO ASSIGNED IT THE SAMPLE ID OF PATIENT A. THE CAUSE OF THE PATIENT IDENTIFICATION NUMBER BEING ASSIGNED TO THE INCORRECT PATIENT WAS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE TEST RESULT OF ONE PATIENT SAMPLE (PATIENT B) WAS UPLOADED ON ANOTHER PATIENT SAMPLE (PATIENT A) ON A CENTRALINK DATA MANAGEMENT SYSTEM. NO INCORRECT PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS A RESULT OF THE EVENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A TEST RESULT UPLOADED ON THE INCORRECT PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518973 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGER JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1